A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inhibitors

  • STATUS
    Recruiting
  • End date
    Oct 27, 2023
  • participants needed
    60
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 14 February 2022
cancer
immunosuppressive
prednisone
treatment regimen
metastasis
avelumab
pembrolizumab
tremelimumab
stereotactic body radiation therapy
nivolumab
ipilimumab
durvalumab
immunosuppressants
immune checkpoint inhibitor
metastatic cancer
atezolizumab
stereotactic body radiotherapy

Summary

Drugs called checkpoint inhibitors help the immune system fight cancer. When the effectiveness of these drugs wears off, it may be possible to renew their effectiveness by combining it with a special type of radiation therapy called stereotactic body radiation therapy (SBRT). SBRT is a commonly used type of radiation therapy that gives high dose radiation with high precision to tumors in 1-5 treatments. Radiation therapy, such as SBRT can also treat sites of metastases. The use of checkpoint inhibitors in combination with SBRT has been suggested to improve the immune response against cancer but has not been tested in a formal clinical trial. Up to three lesions can be treated with SBRT. This study only allows checkpoint inhibitors that are already approved by the Federal Drug Agency (FDA) for the treatment of your disease. All radiation therapy will be done on machines which are FDA approved.

Details
Condition Metastatic Cancer, Melanoma Cancer, Lung Cancer, Bladder Cancer, Renal Cancer, Head/Neck Cancers
Treatment Stereotactic body radiotherapy, Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab
Clinical Study IdentifierNCT03693014
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must have signed and dated an IRB approved written informed consent form in accordance with regulatory and institutional guidelines
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations
Males and females 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 2
Histologically confirmed metastatic cancer of any histology for which there is an FDA indication for an immune checkpoint inhibitor including melanoma, lung, bladder, renal and head/neck cancers
Patient has been receiving treatment with an immune checkpoint inhibitor including but not limited to ipilimumab, nivolumab, avelumab, durvalumab, pembrolizumab, atezolizumab, and tremelimumab for at least 2 months. A combination of these therapies is also permitted. No max prior lines of therapy
Patient has evidence of limited progression (up to 5 lesions either new or increase in at least 25% in the cross-sectional diameter of a known lesion) on most recent systemic imaging as determined by the treating physician. Patients with greater than 5 lesions can be included after discussion with the study investigators
Patient must be eligible to continue to receive an immune checkpoint inhibitor after radiotherapy
Subjects must have at least two lesions
One lesion must be safely amenable to irradiation in the opinion of the treating radiation oncologist. This can be a lesion that was previously irradiated if it is deemed appropriate by the treating physician and principal investigator. Standard MSKCC re-irradiation dose constraints must be met
At least one, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria
Prior palliative or curative radiotherapy must be completed at least 14 days prior to treatment
Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses >10mg/day prednisone or equivalent) must be discontinued at least 14 days prior to radiotherapy administration
Women of childbearing potential must have a negative serum within 7 days prior to treatment, or urine pregnancy test (within 24 hours) (minimum sensitivity 25 IU/L or equivalent units of HCG). Women of childbearing potential must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year
Notes
Women who are not of childbearing potential i.e., who are postmenopausal or surgically sterile as well as azoospermia men do not require contraception
Azoospermic males, and women of childbearing potential who are continuously not heterosexually active, are exempt from contraceptive requirements. However, they still must have a pregnancy test

Exclusion Criteria

Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed. Subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment
Any medical disorder that, in the opinion of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study results
Prior active malignancy within the previous 3 years except for locally curable cancers such as basal or squamous skin cancer, superficial bladder, low risk prostate cancer, breast, or cervix cancer. If other prior malignancy was active within prior 3 years, enrollment requires approval of a principal investigator
Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
Subjects requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents for greater than 5 days) or other immunosuppressive medications within 14 days of study drug administration should be excluded. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
Treatment with any other chemotherapy, radiation therapy, biologics for cancer, or investigational therapy concurrently or within 14 days of enrollment
History of allergy to checkpoint inhibitors
History of severe hypersensitivity reaction to any monoclonal antibody
Women must not be breastfeeding
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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